Navarre Opti-Drain NOD8LPTRecalls & reported problems
Bard Access Systems, Inc. · Navarre Opti-Drain Multi-Use Drainage Catheter, Locking Pigtail, 8 Fr x 30 cm · Class 1
All models of Navarre Opti-Drain (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard Navarre Opti-Drain catheter is a drainage tube used in procedures to drain fluid from the body. The 937 reports mostly describe the catheter breaking, fracturing or separating, and fluid leaking. Some note the trocar needle did not match the catheter length and another device was used instead. The reports include no deaths and 14 injuries, and no recalls name this device. Reports rose to 282 over the last year from 191 in the year before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 901
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 901 adverse event reports that list this exact device (DI 00801741037092), received between Nov 3, 2017 and Sep 14, 2026 — classified as 14 injuries, 887 malfunctions.
The most frequently reported specific device problem is “Fracture” (506 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture506
- Material Separation196
- Fluid/Blood Leak160
- Break131
- Defective Component126
- Nonstandard Device94
- Material Integrity Problem17
- Suction Problem17
Patient problems
- No Clinical Signs, Symptoms or Conditions865
- No Consequences Or Impact To Patient14
- Extravasation8
- Hemorrhage/Blood Loss/Bleeding7
- No Known Impact Or Consequence To Patient5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Infiltration into Tissue3
- Pain3
Recent adverse event reports
The 25 most recent of 901 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Fluid/Blood Leak; Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50751222 ↗MalfunctionSep 14, 2026Break; Material Separation
On (b)(6) 2026, a patient underwent an ultrasound guided abscess percutaneous drainage procedure using the Navarre Opti Drain Drainage Catheter. Prior to the procedure, the thread was found to have completely separated from the catheter. The procedure was completed using another device. There was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749384 ↗MalfunctionSep 14, 2026Break; Material Separation
On (b)(6) 2026, a patient underwent an ultrasound guided abscess percutaneous drainage procedure using the Navarre Opti Drain Drainage Catheter. Prior to the procedure, the thread was found to have completely separated from the catheter. The procedure was completed using another device. There was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749381 ↗MalfunctionSep 14, 2026Break; Material Separation
On (b)(6) 2026, a patient underwent an ultrasound guided abscess percutaneous drainage procedure using the Navarre Opti Drain Drainage Catheter. Prior to the procedure, the thread was found to have completely separated from the catheter. The procedure was completed using another device. There was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749380 ↗MalfunctionSep 8, 2026Fracture
On (b)(6) 2026, a patient underwent an ultrasound guided Percutaneous Transhepatic Cholangial Drainage procedure using the Navarre Opti Drain Drainage Catheter. After the procedure, the drainage catheter connector fractured. The procedure was completed using another device. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50665183 ↗MalfunctionSep 2, 2026Fluid/Blood Leak
A patient underwent an ultrasound guided ascites percutaneous drainage catheter placement procedure using a Navarre Opti Drain Catheter. Following the procedure on (b)(6) 2026, fluid leakage was observed from the small hole of the Sure-Lok component. The procedure was subsequently completed using another device. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50565717 ↗MalfunctionSep 2, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50565715 ↗MalfunctionSep 2, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50565714 ↗MalfunctionSep 2, 2026Fracture
A patient underwent a computed tomography guided hydrothorax percutaneous drainage catheter placement procedure using a Navarre Opti Drain Catheter. Post the procedure on (b)(6) 2026, it was noted that the drainage catheters connector was found to be fractured. The procedure was completed using another device. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50560483 ↗MalfunctionSep 1, 2026Nonstandard Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50539153 ↗MalfunctionAug 5, 2026Break; Material Separation
On (b)(6)2026, a patient prepared for an ultrasound guided percutaneous transhepatic cholangiography drainage (PTCD) catheter placement procedure using a Navarre Opti Drain Catheter. Prior to the procedure, it was noted that the Sure-Lok thread was allegedly broken. The procedure was completed using another device. There was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50138994 ↗MalfunctionJul 1, 2026Nonstandard Device
ON (B)(6) 2026, THE PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE OPTI DRAIN DRAINAGE CATHETER. PRIOR TO THE PROCEDURE, IT WAS NOTED THE LENGTH OF TROCAR NEEDLE WAS LONGER THAN CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25675053 ↗MalfunctionJul 1, 2026Nonstandard Device
ON (B)(6) 2026, THE PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE OPTI DRAIN DRAINAGE CATHETER. PRIOR TO THE PROCEDURE, IT WAS NOTED THE LENGTH OF TROCAR NEEDLE WAS LONGER THAN CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25675050 ↗MalfunctionJul 1, 2026Nonstandard Device
ON (B)(6) 2026, THE PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE OPTI DRAIN DRAINAGE CATHETER. PRIOR TO THE PROCEDURE, IT WAS NOTED THE LENGTH OF TROCAR NEEDLE WAS LONGER THAN CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25675048 ↗MalfunctionJun 30, 2026Break; Material Separation
ON (B)(6) 2026, THE PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE OPTI DRAIN DRAINAGE CATHETER. POST THE PROCEDURE, IT WAS NOTED THAT SURE LOKTM THREAD HAD DIGRESSED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25664503 ↗MalfunctionJun 30, 2026Break; Material Separation
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY DRAINAGE PROCEDURE USING THE NAVARRE OPTI-DRAIN DRAINAGE CATHETER. WHEN THE PACKAGE WAS OPENED, THE THREAD WAS FOUND TO BE COMPLETELY SEPARATED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25663262 ↗MalfunctionJun 30, 2026Nonstandard Device
ON (B)(6) 2026, THE PATIENT UNDERWENT A PLACEMENT PROCEDURE IN PREPARATION FOR AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE PROCEDURE FOR CYST MANAGEMENT. PRIOR TO USE, IT WAS REPORTED THAT THE TROCAR NEEDLE LENGTH WAS SIGNIFICANTLY LONGER THAN THE ASSOCIATED DRAINAGE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25662968 ↗MalfunctionJun 30, 2026Break; Material Separation
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY DRAINAGE PROCEDURE USING THE NAVARRE OPTI DRAIN DRAINAGE CATHETER. WHEN THE PACKAGE WAS OPENED, THE THREAD WAS FOUND TO BE COMPLETELY SEPARATED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25662965 ↗MalfunctionJun 30, 2026Nonstandard Device
ON (B)(6) 2026, THE PATIENT UNDERWENT A PLACEMENT PROCEDURE IN PREPARATION FOR AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE PROCEDURE FOR CYST MANAGEMENT. PRIOR TO USE, IT WAS REPORTED THAT THE TROCAR NEEDLE LENGTH WAS SIGNIFICANTLY LONGER THAN THE ASSOCIATED DRAINAGE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25662964 ↗MalfunctionJun 30, 2026Nonstandard Device
ON (B)(6) 2026, THE PATIENT UNDERWENT A PLACEMENT PROCEDURE IN PREPARATION FOR AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE PROCEDURE FOR CYST MANAGEMENT. PRIOR TO USE, IT WAS REPORTED THAT THE TROCAR NEEDLE LENGTH WAS SIGNIFICANTLY LONGER THAN THE ASSOCIATED DRAINAGE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25662963 ↗MalfunctionJun 22, 2026Fracture
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY DRAINAGE (PTCD) PROCEDURE USING THE NAVARRE OPTI DRAIN DRAINAGE CATHETER. IT WAS REPORTED THAT AFTER THE PROCEDURE, A FRACTURE OF THE DRAINAGE CATHETER CONNECTOR WAS ALLEGEDLY OBSERVED. THE CATHETER WAS REPLACED WITH A NEW DRAINAGE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25574127 ↗MalfunctionJun 21, 2026Fracture
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE OPTI DRAIN DRAINAGE CATHETER. POST THE PROCEDURE, THE DRAINAGE CATHETER CONNECTOR WAS ALLEGEDLY FRACTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25571932 ↗MalfunctionJun 21, 2026Fracture
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE OPTI DRAIN DRAINAGE CATHETER. POST THE PROCEDURE, IT WAS REPORTED THAT THE DRAINAGE CATHETER'S CONNECTOR HAD FRACTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25571931 ↗MalfunctionJun 21, 2026Fracture
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE OPTI DRAIN DRAINAGE CATHETER. POST THE PROCEDURE, THE DRAINAGE CATHETER CONNECTOR WAS ALLEGEDLY FRACTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25571930 ↗MalfunctionJun 21, 2026Fracture
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE OPTI DRAIN DRAINAGE CATHETER. POST THE PROCEDURE, THE DRAINAGE CATHETER CONNECTOR WAS ALLEGEDLY FRACTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25571929 ↗
Other CATHETER, IRRIGATION devices
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- Navarre NNU6LPTBard Access Systems, Inc. · CATHETER, IRRIGATION211 reports
- Navarre Opti-Drain NOD10LPTBard Access Systems, Inc. · CATHETER, IRRIGATION178 reports
- Navarre NNU10LPTBard Access Systems, Inc. · CATHETER, IRRIGATION127 reports
- BLAKE 2233Ethicon Inc. · CATHETER, IRRIGATION114 reports
- Vasoshield VH-5001Maquet Cardiovascular LLC · Catheter, Irrigation1 recall27 reports
- BLAKE 2229Ethicon Inc. · CATHETER, IRRIGATION76 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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